A randomised open-label controlled clinical trial to study the add-on effect of Siravedha with Dadrughna lepa in the management of Dadru kushtha with special reference to Tinea corporis.

This study titled “A Randomised Open-Label Controlled Clinical Trial to Study the Add-on Effect of Siravedha with Dadrughna Lepa in the Management of Dadru Kushtha (Tinea Corporis)” aims to evaluate the effectiveness of Siravedha as an adjunct to Dadrughna Lepa in patients with Dadru Kushtha, a condition described in Ayurveda that closely resembles Tinea corporis and is characterized by itching, erythema, vesicles, and raised circular lesions due to Pitta–Kapha and Rakta vitiation. Tinea corporis affects approximately 7.86% of the Indian population and 20–25% globally, and its chronicity, recurrence, and widespread steroid misuse have resulted in increased treatment failure and poor quality of life. Although Dadrughna Lepa has shown 60–84% symptom improvement, robust randomized controlled trial evidence for its combination with Siravedha is lacking. The study is designed as a randomized open-label controlled clinical trial with a sample size of 66 patients aged 18–60 years, divided equally into two groups. Group A receives Siravedha on Day 1 and Day 8 along with Dadrughna Lepa applied twice daily for 15 days, while Group B receives only Dadrughna Lepa twice daily. Patients are followed up on Day 21, and computer-generated randomization is employed. Subjective parameters such as itching, erythema, vesicles, dryness, and burning sensation, along with objective measures including number and size of lesions, are assessed using a 0–3 grading scale. Investigations include CBC, BT-CT, and HHH. Statistical analysis is performed using the Wilcoxon signed-rank test and Student’s t-test. The study hypothesizes that Siravedha with Dadrughna Lepa will provide superior clinical improvement compared to Dadrughna Lepa alone. This trial is expected to generate scientific evidence supporting the synergistic role of Siravedha with Dadrughna Lepa in managing chronic and recurrent Dadru Kushtha, offering a validated Ayurvedic therapeutic alternative.